TMS for PTSD in Youth

NCT07401225 | Recruiting FDA Device

• 2 other identifiers: STUDY00002052NECMHR02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether transcranial magnetic stimulation, or TMS, is an acceptable and helpful treatment for ongoing symptoms of posttraumatic stress syndrome disorder (PTSD) in 12-20 year olds. Ongoing PTSD refers to symptoms that continue after completing trauma-focused psychotherapy. About 1 in 4 patients need additional help to overcome PTSD after completing psychotherapy. Currently, scientists do not know the best way to help adolescents with persistent PTSD, and this study will test TMS as a possible treatment, and hopefully lead to future studies including more people.

Conditions

Post Traumatic Stress Disorder (PTSD)

Keywords

Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation (TMS)

Outcome Measures

Primary Outcomes (3)

• Side Effects of TMS treatment

  number of side effects reported per participant

  Day 1 of treatment through Day 30

• Number of Adverse Events

  Number of adverse events experienced by study participants through the treatment phase of the study

  Day 1 of treatment through Day 30

• Completion rate of Treatment

  Number of participants that completed the TMS treatment

  Day 1 of treatment through Day 30

Secondary Outcomes (2)

• Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)(CAPS-5)

  Baseline to 90 days

• Assessment of Depression using Patient Health Questionnaire-9 (PHQ-9)

  Baseline to Day 30

Study Arms (1)

TMS treatment group

EXPERIMENTAL

Each treatment visit will take about 1.5 hours. Participants will receive up to 4 TMS treatment sessions during the visit, with each session lasting about 10-minutes. After the TMS sessions, there will be a brief visit with a psychotherapist.

Device: MagPro R30 with robotic arm

Interventions

MagPro R30 with robotic arm DEVICE

TMS will be delivered to the right anterior dorsolateral frontal cortex. The accelerated protocol consists of 1,800 TMS pulses per session, delivered at intensity ranges designed to deliver depth-corrected E-fields of 80-95 volts/meter. The exact intensity will be determined when the participant's treatment plan is developed. Once a patient's TMS treatment plan has been created, it will be used for every treatment session for that participant.

TMS treatment group

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females; Age 12-20
• Have previously completed at least 9 sessions of trauma-focused therapy in our clinical trial or in the community
• Have current self-reported symptom score of 20 or greater on the UCLA PTSD Reaction index
• Willing to attend 10 TMS treatment sessions within a 30-day period
• Fluent in English

You may not qualify if:

• History of seizures
• History of head injury with loss of consciousness and concussive sequelae
• Brain abnormality such as tumor or other observable abnormality
• Currently receiving psychotherapy or TMS treatment
• Currently pregnant
• MRI contraindications (metal in body, orthodontic braces)
• Diagnosis of bipolar 1 or a psychotic disorder

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Texas Child Mental Health Care Consortium: TCMHCC: collaborator

Study Sites (1)

UT Health Department of Psychiatry

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Amy S Garrett, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy S Garrett, PhD

CONTACT

210-567-8189; GarrettAS@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open label single group design

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start (Estimated): May 9, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-02

Locations

US (1)